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ASP1002 for Cancer
Study Summary
This trial studies a new treatment (ASP1002) for people with certain solid tumors. It aims to learn if it has any medical problems or side effects and to find a suitable dose to use in future studies. People will receive infusions & checks during visits over 2 years.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have recent tumor tissue samples available.I have not had major surgery in the last 28 days.My cancer is advanced and cannot be removed by surgery.I have untreated brain metastases.I will not donate eggs during the trial.I have received specific treatments recently.I have not taken steroids or immunosuppressants within the last 14 days.My cancer type is one of the following: NSCLC, urothelial, colorectal, prostate, ovarian, or triple-negative breast.I have had a bone marrow or organ transplant from another person.My condition worsened or I can't tolerate/accept standard treatments.I have not received a live vaccine in the last 28 days.I weigh less than 40 kg.I will need additional cancer treatment while on this study.I stopped my previous immune therapy because of severe side effects.I have needed IV antibiotics for an infection within the last 14 days.I agree not to breastfeed during the trial.I will not donate sperm during the trial.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of lung conditions.I am currently being treated for another type of cancer.I have previously received anti-CD137 therapy.My organs are functioning well enough to start treatment.I will use birth control if my partner is pregnant.I am experiencing significant side effects from previous cancer treatments.I am a man and will use birth control with my partner who can have children.I finished my radiotherapy at least 2 weeks ago.I have had heart problems within a specific time.I am not pregnant and follow the required contraceptive guidelines.
- Group 1: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)
- Group 2: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)
- Group 3: ASP1002 Dose Escalation (Part 1)
- Group 4: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What possible harmful effects could result from administering ASP1002 Dose Escalation (Part 1) to patients?
"Due to the preliminary state of clinical research, our team at Power assigned ASP1002 Dose Escalation (Part 1) a score of one in terms of safety. This is because Phase 1 trials provide limited evidence regarding both efficacy and risk profiles."
How many individuals have elected to participate in this trial?
"Affirmative. According to information available on clinicaltrials.gov, this trial is actively recruiting patients since its posting date of February 21st 2023 and was last updated on March 7th 2023. 210 individuals need to be enrolled across two medical locations."
Is it still possible for individuals to join this clinical experiment?
"Per the clinicaltrials.gov website, this experiment is currently recruiting volunteers and has been receiving updates since its initiation on February 21st 2023. The most recent edit was made on March 7th of the same year."
What are the desired outcomes for this medical experiment?
"The sponsor of this medical trial, Astellas Pharma Global Development Inc., has outlined the primary outcome as Adverse Events (AEs) and physical exam abnormalities over a 24 month period. Secondary outcomes span from Maximum concentration (Cmax), Duration of Response (DOR), to Disease Control Rate (DCR)."
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